Cleared Special

Masimo CARESCAPE SpO2 ? Masimo with SpHb

K221953 · Masimo Corporation · Anesthesiology
Aug 2022
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K221953 is an FDA 510(k) clearance for the Masimo CARESCAPE SpO2 ? Masimo with SpHb, a Oximeter (Class II — Special Controls, product code DQA), submitted by Masimo Corporation (Irvine, US). The FDA issued a Cleared decision on August 4, 2022, 30 days after receiving the submission on July 5, 2022. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 870.2700.

Submission Details

510(k) Number K221953 FDA.gov
FDA Decision Cleared SESE
Date Received July 05, 2022
Decision Date August 04, 2022
Days to Decision 30 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code DQA — Oximeter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2700

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